By JoJo Platt, senior contributing editor
August 20, 2026 | Three events converged this year to turn brain-computer interfaces from a research curiosity into a subject of government strategy. In March 2026, China’s National Medical Products Administration cleared Neuracle Medical Technology’s NEO device for commercial sale, the first invasive motor brain-computer interface in the world cleared for routine clinical use outside a trial. Within 48 hours, China’s National Healthcare Security Administration assigned the device a reimbursement billing code. In May 2025, Elon Musk’s Neuralink raised $600 million at a $9 billion valuation and expanded human trials to four countries. That same month, the European Commission’s Joint Research Centre published a foresight report mapping eight policy areas, from consumer protection to defense and law enforcement, where neurotechnology could outrun existing rules, and urging the EU to start building governance frameworks before the technology matures further.
Three different geographies with three different government postures. China moved a product to market, having already built the machinery to pay for it. The U.S. funded a founder. The European Union asked its regulators to study a problem. This is not an accident of timing. It reflects fundamentally different beliefs about what a government should do when a new technology can read, and may soon write to, the human brain.
The U.S.: Private Capital Leads, Government Follows at a Distance
The American approach to BCIs started, as much American science has, inside government labs. DARPA’s Neural Engineering System Design program alone put $65 million into six university and industry teams starting in 2016, aimed at building a two-way neural interface. But the government’s role has since narrowed. Today the U.S. model runs on private capital, billionaire founders, and a regulator that moves quickly once a device reaches its door. As the FDA’s own designation process shows, though, “quickly” has limits.
Neuralink remains the most visible name in the field, but it is not the only one moving quickly. Musk’s company has expanded human trials across four countries and holds FDA Breakthrough Device designations for both speech restoration and vision restoration. Secondary-market trading has since pushed some private valuations of the company as high as $42 billion. Paradromics is close behind on at least one measure. The company took a strategic investment from NEOM, the Saudi-backed giga-project, in February 2025, completed its first human implant of its Connexus BCI three months later at the University of Michigan, and in November 2025 won FDA investigational device exemption to begin a speech-restoration study, the first such approval for a fully implantable BCI.
Sam Altman has entered the same market from a different angle. His new company, Merge Labs, spun out of the nonprofit Forest Neurotech, which the NIH’s BRAIN Initiative helped incubate starting in 2023. Merge Labs raised a $252 million seed round from OpenAI, Bain Capital, and Gabe Newell, among others, and is building a non-invasive, ultrasound-based interface rather than Neuralink’s implanted chip. Its founding team pairs academic neuroscientists Mikhail Shapiro, Tyson Aflalo, and Sumner Norman with Altman and his fellow entrepreneurs Alex Blania and Sandro Herbig.
Older hardware still runs underneath much of the field. Blackrock Neurotech’s Utah Array, an implanted microelectrode grid first placed in a human brain in 2004, underlies most BCI trials conducted to date, in the U.S. and abroad. Its ownership says as much about where the money in this sector comes from as its technology says about the state of the art. The cryptocurrency company Tether bought a $200 million majority stake in 2024, and earlier backers include Peter Thiel and the German financier Christian Angermayer.
Synchron and Precision Neuroscience round out the field of well-capitalized U.S. developers. Synchron, whose Stentrode reaches the brain through a blood vessel rather than open surgery, closed a $200 million Series D in November 2025 backed by Bezos Expeditions, the Qatar Investment Authority, and Australia’s National Reconstruction Fund, among others, ahead of a planned 2026 pivotal trial. Precision Neuroscience, building a thinner, less invasive surface array, has raised roughly $200 million across its Series C and a further round in March 2026.
The FDA has no BCI-specific approval pathway. What it has is the Breakthrough Devices program, which grants qualifying technologies more frequent, structured engagement with agency reviewers: priority placement in the review queue, dedicated senior reviewers, and more frequent meetings during development. That is not a small thing. Closer, earlier FDA engagement lets a small company catch a flawed trial design or a thin evidence package months before a rejection would otherwise surface it. But it is not an approval, and it is not a shortcut around the FDA’s evidence standards. A breakthrough-designated device still has to clear the same 510(k), de Novo, or PMA review as anything else. In April 2026, the German company CorTec received Breakthrough Device Designation for its Brain Interchange System, a closed-loop implant that reads and stimulates the brain to support motor recovery in chronic stroke patients. It was the first BCI worldwide designated for that use. Even with the designation’s structural advantages, the best-case U.S. timeline still averages just over 300 days, nearly double the average for China’s comparable fast-track review.
Reimbursement has been slower still to organize. The U.S. has no equivalent to China’s standing, pre-built pricing infrastructure; coverage decisions have historically followed approval rather than anticipating it. That began to change only this year: soon after NEO’s approval and billing-code assignment in China, the U.S. Centers for Medicare and Medicaid Services and the FDA jointly announced the RAPID coverage pathway, intended to synchronize FDA market authorization with Medicare national coverage determinations for Class II and Class III breakthrough devices. It is a reactive fix, built after the fact, to a problem China’s regulators anticipated years in advance.
On privacy, too, Congress has only just begun to act. The MIND Act, introduced by Senators Cantwell, Schumer, and Markey in September 2025, would direct the FTC to spend a year studying how to govern neural data. That is a study, not a rule. On export policy, the Commerce Department’s Bureau of Industry and Security first flagged brain-computer interfaces as an emerging technology needing possible export controls back in 2018 and still has not finalized a rule. Meanwhile, the Committee on Foreign Investment in the United States and the newer outbound-investment screening regime aimed at China cover neurotechnology only by proximity, as part of broader restrictions on AI, quantum computing, and biotech.
Put together, the US approach adds up to a bet: let billionaires and venture capital pick the winners, keep the FDA’s door open to the fastest-moving devices, and build the reimbursement and privacy machinery after a product exists rather than before. Speed to the clinic is the point. Speed to the pharmacy counter, and clarity about the data a device generates, are still catching up.
China: A Named Industry, an Institute, and Infrastructure Built Years in Advance
China’s government has stopped treating BCIs as a research topic and started treating it as a named industry. The 15th Five-Year Plan, covering 2026 through 2030, lists BCI for the first time among six industries the state has chosen to cultivate, alongside quantum technology and humanoid robots. In August 2025, several government ministries jointly issued guidelines meant to speed the industry’s growth, setting a target of major technical breakthroughs by 2027 and two or three globally competitive Chinese BCI companies by 2030.
Money has followed the plan. Beijing’s municipal government is funding the Chinese Institute for Brain Research directly, with $29 million in its first year and a planned $65 million a year after that. Private capital has moved even faster: venture funding for Chinese BCI companies reached 6.47 billion yuan, or about $890 million, in the first half of 2026 alone, up from 1.5 billion yuan for all of 2025.
The clearest evidence of the state’s approach came in March 2026, when the National Medical Products Administration (NMPA) cleared Shanghai-based Neuracle Medical Technology’s NEO device for commercial use. NEO is a coin-sized implant, developed with Tsinghua University, that sits on the dura mater and uses eight sensors. It helps patients with C2-C6 cervical spinal cord injuries regain hand movement through a paired robotic glove. It was the first regulatory clearance anywhere in the world for an invasive motor BCI outside a clinical trial.
What happened in the 48 hours after that approval matters more than the approval itself. China’s National Healthcare Security Administration (NHSA) assigned NEO a reimbursement billing code almost immediately. That was possible because NHSA had built the pricing infrastructure a year before NEO existed. Chinese medical service pricing is organized around technology and procedure categories rather than named products, and NHSA has a standing process for defining those categories through expert consultation before any specific device is there to fill them. Once NMPA clears a product, it is simply slotted into an already-defined category. The approval was the last step in a reimbursement framework designed well ahead of it.
The regulatory speed itself is also engineered. NMPA’s Innovative Medical Device Special Review Procedure requires an applicant to hold a Chinese patent on the device’s core mechanism and to show that its primary working principle is first-in-China; qualifying devices get priority testing and evaluation. In 2024, devices approved through this procedure took an average of 180 days, roughly half the standard review timeline.
The same state that funds and clears BCI technology has also drawn talent trained elsewhere, and not always by ordinary means. Charles Lieber, once a leading Harvard chemist, was convicted in 2021 of lying to U.S. authorities about his ties to China’s Thousand Talents recruitment program. He now runs a Chinese government-backed BCI institute in Shenzhen. The U.S. National Counterintelligence and Security Center has separately warned that Chinese intelligence services actively recruit researchers and students at American universities, in ways that have led to export-control violations and the theft of trade secrets. The Pentagon has said Chinese military researchers are examining brain interfaces for cognitive-enhancement uses in soldiers.
Duke law professor Nita Farahany, who has spent a decade warning about the ethical stakes of neurotechnology, points to China as the clearest example of what happens when a state applies these tools at national scale rather than waiting for consensus on their limits. She has described brainwave-monitoring caps already worn by workers on Chinese factory floors, trains, and construction sites, devices that track fatigue and attention and feed the results back to employers and, in some cases, the state. “There are a lot of declassified documents that have come out of China that suggest that they’re investing a lot in purported brain-disrupting technology,” she said on the 80,000 Hours podcast in 2023. That testimony was serious enough that the Biden administration sanctioned four Chinese companies that year over alleged brain-control weapons research. Farahany has also argued that China’s use of platforms like TikTok belongs in the same category of “cognitive warfare” as its BCI programs: different tools aimed at the same target, the boundary between a person’s private thoughts and a government’s reach into them.
Beijing controls a lever the rest of the industry needs too. Its October 2025 expansion of export controls on rare earth elements and permanent magnets, covering elements like dysprosium, terbium, and samarium, was aimed broadly at chips and defense electronics, not BCI specifically. But it is a reminder that China can restrict hardware inputs its rivals need even as it races to beat them to market.
The Chinese approach amounts to a different bet than the American one. The state names the target, funds the institute, sets the deadline, and, critically, builds the regulatory and reimbursement machinery years before a product exists to use it, so that approval and adoption arrive almost simultaneously.
The European Union: Rules Before Devices
No EU BCI company has a funding round or a market authorization to match Neuralink’s or Neuracle’s. That gap is not an accident; it is close to the point. The EU’s starting position is that the rules should exist before the devices reach people, not after.
The EU’s AI Act, formally Regulation 2024/1689, does not name BCIs directly, but its risk-tiered structure catches most of what BCI devices actually do: real-time interpretation of brain signals, adaptive neuromodulation, and automated detection of neurological conditions all fall under its rules for high-risk AI systems. Article 5, in force since February 2025, bans AI systems that manipulate a person’s behavior without their awareness, with a narrow exception for consented medical treatments like deep brain stimulation. The AI Act sits on top of GDPR, which already treats health data as a special category requiring stronger consent, and which regulators expect to extend to neural data specifically. European officials increasingly describe the goal as protecting “neuro-rights,” meaning a person’s claim to mental privacy and self-determination, as a founding principle of the technology’s regulation, not an afterthought bolted on once products exist.
That does not mean Europe lacks capital or ambition. Munich-based FUTRUE Neurosciences, founded by the German pharmaceutical entrepreneur Clemens Fischer, is developing a surface-mounted electrode array with 512 channels that Fischer has said he wants to make the world’s leading BCI platform by 2030, a deliberately less invasive alternative to Neuralink’s implant. Fischer built his roughly $1 billion fortune through FUTRUE Group, a Munich holding company with more than 20 pharmaceutical and drug-development firms, and FUTRUE Neurosciences reported its first major technical milestone in March 2026.
Not all European money stays in Europe. Christian Angermayer, the German financier behind Apeiron Investments, has also backed psychedelic and longevity ventures. His largest BCI bet sits not in Germany but in Utah, where his stake in Blackrock Neurotech has produced a reported fivefold return. It is a small but telling asymmetry: European capital chasing American hardware even as European rules stay cautious about deploying either at home. Germany’s own CorTec, which built the country’s first implantable BCI, shows the same pull in a different form. Its fastest current route to patients runs through the FDA’s Breakthrough Devices program in the U.S., not through a comparable EU mechanism. Barcelona’s INBRAIN Neuroelectronics, developing a graphene-based interface backed by a $50 million Series B from Earlybird Venture Capital, is one of the few EU-based developers building both the technology and a path to market at home.
The European bet is that legitimacy outlasts speed. GDPR is a useful test of that theory: other jurisdictions eventually copied it even though the U.S. and China had moved faster on the underlying technology first. On that evidence, the EU may be betting correctly.
Export Controls as the New Front Line
None of the three governments has built an export-control regime specifically for BCIs. All three are already treating adjacent levers as if that regime existed. The U.S. has spent seven years considering, without finalizing, export controls on BCI itself, while its outbound-investment screening and CFIUS review process lump neurotechnology in by association with AI, quantum computing, and biotech. China’s sweeping October 2025 controls on rare earth elements and magnets were not written with brain implants in mind, but they touch the electronics every BCI maker, American or European, depends on. The EU’s dual-use export regime and the extraterritorial reach of the AI Act mean that any device sold into the European market must clear European rules regardless of where it was built or funded.
The result is a field where the hardware supply chain, the capital that funds it, and the data it produces are already subject to three different, only partly compatible, rulebooks, well before any of the three governments has finished writing rules built for the technology itself.
Ideology as Strategy
Line up the three approaches and a pattern appears, one that goes beyond who funds research and who writes rules. The U.S. leans on private capital, billionaire founders, and a light regulatory hand at the approval stage, then builds the reimbursement and privacy machinery only once a product forces the question. The RAPID pathway arrived after NEO, not before, and the MIND Act is still just a proposal to study the issue. China does the administrative work first: it names the industry, funds the institute, and builds both the fast-track regulatory pathway and the reimbursement pricing categories years before a specific device exists to use them, backed by a security service willing to recruit talent trained elsewhere. The European Union is betting that writing the rulebook first, and building “neuro-rights” from the start, is worth the cost of moving slower than its rivals, a bet its own companies sometimes hedge against by seeking their fastest path to market in the US instead.
Each bet aims at a different kind of win. The U.S. may end up with the best-funded labs and the most famous founders. China may get the first product to market, the fastest path to scale, and patients who can access a covered device almost as soon as it is cleared. The EU may get the standard that other jurisdictions eventually adopt, the way GDPR became a template well beyond Europe’s borders even though American and Chinese firms had moved faster on the underlying technology.
Farahany argues the stakes go beyond who wins commercially. She has called the right to “cognitive liberty”—meaning self-determination over one’s own brain and mental experience—a claim that draws “rare unanimity” among people who otherwise disagree about almost everything else politically. Her point is that a device implanted in one country’s citizens under one set of rules can still shape a global argument about what any government, anywhere, should be allowed to know about a person’s mind. The country that sets the rule the rest of the world eventually copies may end up mattering more than the country that ships the first device.
What This Means for the Field
Researchers and companies working across borders now face forked standards, a widening contest for talent, and capital that increasingly comes with a flag attached. Patients, meanwhile, may see the fastest access to a covered device in China, the deepest funding pipeline in the U.S., and the strongest privacy protection in the EU. These are three different products of three different beliefs about what a government owes its citizens when a machine can read their thoughts.
None of the three regulatory regimes discussed here, not NMPA’s and not FDA’s, actually governs what happens to a patient’s neural data after it is collected: who controls it, whether it can be reused to train AI systems, how long it is retained, or whether inferences drawn from brain activity deserve protections beyond ordinary health information. Those questions currently fall to a patchwork of medical device law, privacy law, cybersecurity rules, research ethics, and general data protection statutes, with a handful of U.S. states now passing legislation specific to neural data. The OECD has argued that existing regulatory systems were built to evaluate device safety, not to govern the broader societal implications of a technology that reads the brain, and has recommended a mix of technical standards, corporate governance, and international coordination while more comprehensive legal frameworks develop.
None of this requires a new statute to get started. The FDA and the Cybersecurity and Infrastructure Security Agency have run a formal coordination agreement on medical device cybersecurity since 2018; widening that same structure to include the FTC and HHS could bring neural-data reuse, retention, and AI-training rights under the kind of standing oversight device cybersecurity already has. Consent is the piece closest to patients directly: a single signature at implantation today typically covers clinical use, research use, and downstream commercial or AI-training use in one moment, even though BCI devices collect data continuously for months or years rather than in the single sitting a scan or a blood draw requires. Unbundling that signature and giving patients some ongoing way to revisit or revoke each piece of consent, would not need Congress or Brussels to first agree on what neural data is in a legal sense.
Speed is not the part of China’s approach that other jurisdictions most need to copy. Foresight is: the regulatory, financial, and now data-governance infrastructure needs to exist before the next approval forces the question, not after.
